MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	705.13P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that ophthalmic forceps tips were not opening properly during insertion.The surgery was completed after replacing the product with another one.There was no patient harm.The procedure type and patient details were unknown.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the database for the non-conformance events and the complaints showed that the given lot number was not concerned by any relevant deviation and that there are no additional complaints associated with it.The investigation is concluded based on the sample evaluation outlined below.The sample was received in stuck with tape to the outer blister and covered with the tyvek lid foil showing the lot information.The sample shows no macroscopic signs of damage and was returned in open state.The sample exhibits a significant amount of surgery residues.The sample was visually inspected with the aid of a photomicroscope using various magnifications and was functionally tested.During the inspection, it was confirmed that the forceps gets stuck in a closed state and can only get opened again by manually pushing down the metal shaft, indicating the bonding connection between the shaft and the sleeve got broken.This confirms the customer¿s complaint.As the blister was opened by the customer and there being surgery residues on the forceps tip, the product was handled and used on a patient.Therefore, it is not possible to determine what situation could have caused the malfunction and no root cause can be identified conclusively.Since the situation that lead to the damage can not be reconstructed, a root cause for the customer's reported event cannot be determined.The exact root cause for the customers reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19545738
• Report Number: 3003398873-2024-00061
• Device Sequence Number: 4733918
• Product Code: HNR
• UDI-Device Identifier: 07612717070721
• UDI-Public: (01)07612717070721(17)250531(11)220627(10)14V2AE(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 705.13P
• Device Lot Number: 14V2AE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 08/28/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/28/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM
• Patient Sex: Unknown